Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)

Launched by UNIVERSITY OF PITTSBURGH · Nov 2, 2010

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Having persistent AF, defined as AF that does not self terminate for at least 24 consecutive hours.
• • In AF upon entry into the operating room for CRT-D implantation and AV node ablation.
• • Being on a stable dosage of an ACE inhibitor or ARB for at least 1 month preceding implant
• • Being on a Beta-blocker for at least 3 months preceding implant and a stable dosage within 1 month of implant
• • Not taking or able to be taken off all type I/III antiarrhythmic medications.
• • Taking Coumadin so as to maintain an INR of between 2 and 3.
• • A Class I or IIa ICD indication
• • NYHA Class III/IV within 1 month of baseline
• • Intrinsic QRS duration ≥ 130 ms within 1 month prior to baseline
• • Left ventricular ejection fraction ≤ 35% (method per physician discretion) within 1 month prior to baseline
• • Left ventricular end diastolic dimension (LVEDD) ≥ 55 mm (method per physician discretion) within 1 months prior to baseline
• • Willing to provide written informed consent
• • Are expected to survive for 6 month of study participation
• • Able to tolerate an urgent thoracotomy
• • Able to tolerate \< 1 mg dexamethasone sodium phosphate (steroid)
• Exclusion Criteria:
• • Having self-terminating or interminable AF
• • Having unstable angina, or having experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within the past 1 month
• • Post-heart transplant (patients on heart transplant list for the first time are not excluded)
• • Having mechanical right heart valve
• • Having an existing CRT or atrial therapy device(s)
• • Being enrolled in any concurrent drug and/or device study which would confound the results of this trial
• • Having primary valvular disease and indicated for valve repair or replacement
• • Having a previous AV node ablation
• • Being on a Type I or Type III anti-arrhythmic medication for the treatment of ventricular tachyarrhythmias
• • Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control